Rib Raising for Post-operative Ileus

Not Applicable

Completed

• Conditions: Intestinal Pseudo-Obstruction; Manipulation, Osteopathic; Osteopathic Medicine; Postoperative Nausea and Vomiting; Postoperative Complications; Postoperative Care
• Interventions: Procedure: Sham procedure; Procedure: Rib raising and lumbar release

• Registration Number: NCT03662672
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

We are conducting a randomized controlled trial the use of rib raising for post-operative ileus. Rib raising is an osteopathic manipulative technique (OMT). We will recruit all patients undergoing major abdominal surgery and once they have been enrolled, we will randomize them to receive daily rib raising or a control technique where we place hands on the back but do not apply any pressure. In preliminary studies, Rib raising has been shown to reduce post-operative ileus and hospital length of stay by up to 50%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-09-27
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)

Exclusion Criteria

• Open abdomen for >72 hours
• Prior history of major post-operative complications
• Intolerance to anesthesia
• Co-morbidities including osteoporosis and osteopenia
• Spine or rib fractures
• Pregnancy
• Prisoners
• History of osteopathic manipulation
• Recruitment delayed beyond 48 hours
• Surgeon requested exclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Intervention	Sham procedure	We will do daily sham intervention from the 5th thoracic vertebra to the 2nd lumbar vertebra where we place our hands under the ribs for 2 minutes per side and under the lumbar area for 2 minutes without applying any pressure (or applying pressure into the bed).
Rib-raising Intervention	Rib raising and lumbar release	We will do daily rib raising and lumbar release from the 5th thoracic vertebra to the 2nd lumbar vertebra for 2 minutes per side for rib raising and 2 minutes for lumbar release.

Primary Outcome Measures

Name	Time	Method
Length of Stay	0-14 days

Secondary Outcome Measures

Name	Time	Method
Time to first bowel movement	0-14 days
Time to first flatus	0-14 days
Nausea/vomiting postop	0-14 days
Need for nasogastric tube postop	0-14 days
Time to first meal	0-14 days

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Newark, New Jersey, United States